Dilute Bleach Compresses for Radiation Dermatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-09

Study Completion Date

2023-04-01

Brief Summary

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This study is looking at the safety of applying dilute bleach compresses to patients receiving radiation therapy and the impact of these dilute bleach compresses on the frequency and severity of skin changes that occur during radiation therapy.

The names of the study interventions involved in this study are:

* Di-Dak-Sol: dilute bleach compresses
* White petrolatum ointment

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Detailed Description

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This is a planned open-label prospective clinical trial to determine the safety of applying dilute bleach compresses to pediatric patients being treated for rhabdomyosarcoma and other soft tissue and bone sarcomas with radiation therapy (RT).

This study is interested in finding out whether dilute bleach compresses are safe to apply and evaluating their impact on the frequency and severity of skin changes that occur in children who are receiving radiation therapy for cancer treatment.

This information may help treat other patients receiving radiation therapy for cancer treatment in the future.

The research study procedures include screening for eligibility and study treatment including weekly evaluations and follow up visits

Participants will receive study treatment throughout their radiation therapy and for one week after. They will be followed for one month after the completion of radiation.

It is expected that about 12 people will take part in this research study.

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Conditions

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Radiation Dermatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Di-Dak-Sol + White Petrolatum

Participants will receive Di-Dak-Sol (dilute bleach compresses) prior to receiving radiation. This will continue throughout their radiation therapy and for one week after.

Participants will also be asked to apply white petrolatum ointment 2x daily throughout treatment: once after radiation and once in the evening.

Participants will be provided with a log and asked to document information (dates/times of application) about the study treatment .

Group Type EXPERIMENTAL

Di-Dak-Sol

Intervention Type DRUG

Topical solution applied externally.

White Petrolatum

Intervention Type OTHER

Topical ointment applied externally

Interventions

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Di-Dak-Sol

Topical solution applied externally.

Intervention Type DRUG

White Petrolatum

Topical ointment applied externally

Intervention Type OTHER

Other Intervention Names

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Sodium Hypochlorite Diluted NaOCl Petroleum jelly Soft paraffin Multi-hydrocarbon

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with a rhabdomyosarcoma or other sarcoma requiring RT
* 12 to 25 years of age
* Scheduled for a RT planning session (CT simulation)
* Have a scheduled RT start date within 1 to 2 weeks from the CT simulation
* Will be receiving doses of radiotherapy greater than at least 36 Gy
* Subjects may participate in other studies, including therapeutic trials.
* Ability to comply with at-home dilute Di-Dak-Sol compresses for final week of dilute Di-Dak-Sol compresses following radiation treatment.
* Ability to understand and/or the willingness of their parent or legally authorized representative to sign a written informed consent document.

Exclusion Criteria

* Patients who are pregnant, which may result in discontinuation of RT
* Presence of inflammatory skin lesions in the radiation field that could interfere with assessment

Minimum Eligible Age

12 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No